This seminar will walk the attendee through 10 critical steps in the development of perfect Standard Operating Procedures. Step-by-step instructions will be provided, with case studies to emphasize the common mistakes and potential solutions.
This seminar will help you evaluate your current SOPs for the presence of most common issues identified by FDA during audits. You will get practical tips and tested strategies for creating, revising, updating, training, and documenting SOP processes at your organization. The case studies will highlight the key concepts, alternate methods, and least-burdensome approach to compliance with FDA regulations.
Formal and written Standard Operating Procedures (SOPs) are keystones of good operations. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This seminar will provide step by step instructions to create SOPs for FDA-regulated organizations. The author will discuss case studies and examples to highlight the common errors and potential solutions. Additionally, the logistics of creating, maintaining, scope, training and documentation will be reviewed. Pros and Cons of paper and electronic SOPs will also be discussed. This seminar contains a collection of practical tips from the trainer’s extensive FDA audit experience.
Areas to be Covered:
Essential elements of an SOP
Process mapping techniques to define the contents of an SOP
Role of personnel in creating SOPs
SOP revisions, updates, creation, retirement and documentation
Categorization of SOPs
Assessment of compliance techniques
Training practices for FDA compliance
Access and access control to SOPs
Who will Benefit:
Senior management executives (CEO, COO, CFO, etc)
Manufacturing managers, supervisors and personnel
Clinical and preclinical laboratory managers
Clinical trial specialists
People investing in FDA-regulated product development projects